Side effects of the device becoming fractured and FDA warnings
Pulmonary embolism is a condition that threatens many individuals suffering from deep vein thrombosis, as the severe blood clots in their legs can travel to the lungs. Medical devices exist to prevent the migration of these blood clots, including the Bard G2 IVC Filter. The Bard G2 IVC Filter is a temporary device, surgically implanted into patient’s interior vena cava designed to catch these blood clots before they reach the lungs, according to the website of Habush Habush & Rottier. The device seemed like a welcome option for individuals who were unable to take blood thinners, but soon adverse side effects began to surface.
Soon after the device’s inception, the Food and Drug Administration began receiving hundreds of reports of medical conditions and side effects that had been caused by the device. Patients began experiencing serious complications of the filter, one of the most prominent being fracture of the device. The fracture of the device could lead to doctors being unable to remove the temporary device from the body. Fracture of the device could also lead to serious heart complications including cardiac tamponade, perforation of the heart, and laceration of the heart just to name a few.
The medical device leads to numerous other complications leading to an official warning from the FDA in 2010 against the unpleasant effects of the device. The FDA officially stated that the device posed the threat of fracture and migration of the device and should be removed as soon as the threat of blood clots subsided. However, the warning came too late for many individuals.
The IVC Filter, originally meant to help individuals, has led to serious medical problems and countless individuals suffering from the device after the company failed to warn patients of the risks. The device fracturing is just one of the dangers of the device as complications continue to arise from the filter.